Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 9, 2021

Primary Completion Date

June 1, 2026

Study Completion Date

June 1, 2027

Conditions
Open WoundWound Heal
Interventions
DRUG

Micro/nanobubble (MNB) - Irrigation

An MNB solution will be used as an irrigation solution to improve wound oxygenation in ischemic tissue (e.g. ischemic surgical tissue, traumatic wounds, and failing replants). The MNB solution will be used in wet-to-dry wound care dressings with daily scheduled dressing changes.

OTHER

0.9% Normal Saline - Irrigation

A normal saline solution will be used as an irrigation solution to improve wound oxygenation in ischemic tissue (e.g. ischemic surgical tissue, traumatic wounds, and failing replants). The normal saline solution will be used in wet-to-dry wound care dressings with daily scheduled dressing changes.

DRUG

Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi)

NPWTi with MNB will be applied to the wound with 20-minute instillation periods every 3 hours (standard instillation settings) with dressing changes every 3-5 days.

OTHER

0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)

NPWTi with normal saline will be applied to the wound with 20-minute instillation periods every 3 hours (standard instillation settings) with dressing changes every 3-5 days.

Trial Locations (1)

92868

RECRUITING

UCI Medical Center, Orange

All Listed Sponsors
lead

University of California, Irvine

OTHER